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Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)

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ClinicalTrials.gov Identifier: NCT01391546
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

PRIMARY OBJECTIVES

Two co-primary objectives are:

  • To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC)
  • To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of varicella zoster virus (VZV) antibody titre from pre to 4-week post-vaccination

SECONDARY OBJECTIVES

Immunogenicity objectives

  • To evaluate the immunogenicity as measured by VZV antibody titre at 4 weeks following ZOSTAVAX administered by IM or SC route
  • To evaluate the immune response as measured by a second assay, the VZV Interferon gamma Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or SC route

Safety objective

- To describe the safety profile of ZOSTAVAX administered by IM or SC route


Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: ZOSTAVAX Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ZOSTAVAX When Administered by Intramuscular Route or Subcutaneous Route to Subjects of 50 Years of Age and Older
Actual Study Start Date : June 30, 2011
Primary Completion Date : July 31, 2013
Study Completion Date : July 31, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ZOSTAVAX intramuscular (IM) route
Single dose of 0.65 mL via IM injection
Biological: ZOSTAVAX
1 dose 0.65 mL
Other Name: V211
Active Comparator: ZOSTAVAX subcutaneous (SC) route
Single dose of 0.65 mL via SC injection
Biological: ZOSTAVAX
1 dose 0.65 mL
Other Name: V211


Outcome Measures

Primary Outcome Measures :
  1. Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination [ Time Frame: 4 week post-vaccination ]
    Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).

  2. Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route [ Time Frame: Pre-vaccination (Day 0) and 4 week post-vaccination ]
    Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination


Secondary Outcome Measures :
  1. Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route [ Time Frame: Pre-vaccination (Day 0) and 4 week post-vaccination ]
    Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-vaccination/GMT Pre-vaccination

  2. Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies [ Time Frame: 4 week post-vaccination ]
    Blood samples taken 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMC's. Results were reported as ELISPOT count/10^6 Peripheral Blood Mononuclear Cells (PBMC)

  3. Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies [ Time Frame: Pre-vaccination (Day 0) and 4 week post-vaccination ]
    Blood samples taken pre-vaccination and 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMFR.

  4. Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction [ Time Frame: up to 28 days after vaccination ]
    Participants entered data into daily diary card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain for 1st 4 days post-vaccination. Additionally, injection site reactions not prompted on diary card (unsolicited) were collected up 28 days post-vaccination. All injection site reactions (solicited or unsolicited) were recorded.

  5. Percentage of Participants Who Report at Least 1 Systemic Adverse Event [ Time Frame: up to Day 28 after vaccination ]
    An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized. These events included rashes of interest: i.e. Varicella, Varicella-like rashes, Herpes zoster or shingles and Herpes zoster-like rashes and other systemic adverse events.

  6. Percentage of Participants Who Report at Least 1 Serious Adverse Event [ Time Frame: up to 35 days after vaccination ]
    A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. The percentage of participants who reported an SAE within 35 days of vaccination were recorded.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults aged >=50 years
  • Varicella history-positive or residence for >30 years in a country with endemic VZV infection

Exclusion Criteria:

  • Febrile illness
  • History of hypersensitivity or anaphylactoid reaction to any of the vaccine components
  • Prior herpes zoster episode clinically diagnosed or exposure to varicella or herpes zoster within the 4 weeks prior to vaccination
  • Prior receipt of varicella or zoster vaccine
  • Active untreated tuberculosis
  • Thrombocytopenia, any other coagulation disorder contraindicating intramuscular injection
  • Receipt of medication / vaccine that may interfere with study assessments
  • Known or suspected immune dysfunction
  • User of recreational / illicit drugs or subject with alcohol abuse or dependence within the last year
  • Any condition that might interfere with the interpretation of the study,
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391546


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01391546     History of Changes
Other Study ID Numbers: V211-045
ZTV03C ( Other Identifier: MCMVaccBV (SPMSD) Protocol Number )
V211-045 ( Other Identifier: Merck Protocol Number )
2009-012458-19 ( EudraCT Number )
First Posted: July 12, 2011    Key Record Dates
Results First Posted: November 20, 2017
Last Update Posted: November 20, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases